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Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function After Kidney Transplantation

NCT ID: NCT06830798

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-19

Study Completion Date

2028-11-06

Brief Summary

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The primary objective of this study is to demonstrate the efficacy of ravulizumab vs placebo in reducing the severity of DGF as measured by time to freedom from dialysis in adult participants who are at high risk of DGF after undergoing transplant of deceased donor kidney.

Detailed Description

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AWAKE is a multicenter, prospective study to evaluate the safety and efficacy of ravulizumab in reducing delayed graft function (DGF) in kidney transplant recipients at high risk for DGF. Eligible participants will be randomized in a 1:1 ratio to receive either ravulizumab or placebo intravenously.

Conditions

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Delayed Graft Function DGF Kidney Transplant

Keywords

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Delayed Graft Function DGF Kidney Transplant Ravulizumab

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ravulizumab

Participants will receive an IV dose of ravulizumab.

Group Type EXPERIMENTAL

Ravulizumab

Intervention Type DRUG

Participants will receive ravulizumab via intravenous (IV) infusion.

Placebo

Participants will receive an IV dose of placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will receive placebo via intravenous (IV) infusion.

Interventions

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Ravulizumab

Participants will receive ravulizumab via intravenous (IV) infusion.

Intervention Type DRUG

Placebo

Participants will receive placebo via intravenous (IV) infusion.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ≥ 18 years of age at the time of signing the informed consent
* Diagnosed with Dialysis-dependent End-Stage Kidney Disease (ESKD)
* A candidate for kidney transplant from:

1. Donation after Circulatory Death (DCD) donor
2. High-risk Donation after Brain Death (DBD) donor

Exclusion Criteria

* Is to receive a kidney from a donor with category I,II,IV and V Maastricht Classification
* Diagnosed with Acute Kidney Injury (AKI) of Stage 3 severity according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Phoenix, Arizona, United States

Site Status RECRUITING

Research Site

Los Angeles, California, United States

Site Status RECRUITING

Research Site

San Francisco, California, United States

Site Status WITHDRAWN

Research Site

San Francisco, California, United States

Site Status RECRUITING

Research Site

Stanford, California, United States

Site Status NOT_YET_RECRUITING

Research Site

New Haven, Connecticut, United States

Site Status RECRUITING

Research Site

Jacksonville, Florida, United States

Site Status RECRUITING

Research Site

Tampa, Florida, United States

Site Status RECRUITING

Research Site

Atlanta, Georgia, United States

Site Status RECRUITING

Research Site

Chicago, Illinois, United States

Site Status RECRUITING

Research Site

Chicago, Illinois, United States

Site Status NOT_YET_RECRUITING

Research Site

Fairway, Kansas, United States

Site Status RECRUITING

Research Site

Lexington, Kentucky, United States

Site Status RECRUITING

Research Site

Kenner, Louisiana, United States

Site Status RECRUITING

Research Site

Ann Arbor, Michigan, United States

Site Status RECRUITING

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Detroit, Michigan, United States

Site Status RECRUITING

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Minneapolis, Minnesota, United States

Site Status NOT_YET_RECRUITING

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St Louis, Missouri, United States

Site Status RECRUITING

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Omaha, Nebraska, United States

Site Status RECRUITING

Research Site

Livingston, New Jersey, United States

Site Status RECRUITING

Research Site

New York, New York, United States

Site Status WITHDRAWN

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New York, New York, United States

Site Status RECRUITING

Research Site

Durham, North Carolina, United States

Site Status RECRUITING

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Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Research Site

Greenville, South Carolina, United States

Site Status RECRUITING

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Nashville, Tennessee, United States

Site Status RECRUITING

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Dallas, Texas, United States

Site Status RECRUITING

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Houston, Texas, United States

Site Status RECRUITING

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Charlottesville, Virginia, United States

Site Status NOT_YET_RECRUITING

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Richmond, Virginia, United States

Site Status RECRUITING

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Seattle, Washington, United States

Site Status RECRUITING

Research Site

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Research Site

Buenos Aires, , Argentina

Site Status RECRUITING

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Buenos Aires, , Argentina

Site Status RECRUITING

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Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

Research Site

Capital Federal, , Argentina

Site Status NOT_YET_RECRUITING

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Córdoba, , Argentina

Site Status NOT_YET_RECRUITING

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Adelaide, , Australia

Site Status RECRUITING

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Brisbane, , Australia

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Camperdown, , Australia

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Murdoch, , Australia

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Innsbruck, , Austria

Site Status RECRUITING

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Vienna, , Austria

Site Status RECRUITING

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Belo Horizonte, , Brazil

Site Status RECRUITING

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Belo Horizonte, , Brazil

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Research Site

Botucatu, , Brazil

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Botucatu, , Brazil

Site Status RECRUITING

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Campinas, , Brazil

Site Status NOT_YET_RECRUITING

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Fortaleza, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre, , Brazil

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Recife, , Brazil

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Rio de Janeiro, , Brazil

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São José do Rio Preto, , Brazil

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São Paulo, , Brazil

Site Status RECRUITING

Research Site

Edmonton, Alberta, Canada

Site Status NOT_YET_RECRUITING

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Vancouver, British Columbia, Canada

Site Status RECRUITING

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Toronto, Ontario, Canada

Site Status NOT_YET_RECRUITING

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Toronto, Ontario, Canada

Site Status NOT_YET_RECRUITING

Research Site

Guangzhou, , China

Site Status NOT_YET_RECRUITING

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Guangzhou, , China

Site Status NOT_YET_RECRUITING

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Guangzhou, , China

Site Status NOT_YET_RECRUITING

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Hangzhou, , China

Site Status NOT_YET_RECRUITING

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Hengyang, , China

Site Status NOT_YET_RECRUITING

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Nanning, , China

Site Status NOT_YET_RECRUITING

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Shenzhen, , China

Site Status NOT_YET_RECRUITING

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Taiyuan, , China

Site Status WITHDRAWN

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Taiyuan, , China

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Tianjin, , China

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Zhengzhou, , China

Site Status NOT_YET_RECRUITING

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Hradec Kralova, , Czechia

Site Status RECRUITING

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Ostrava, , Czechia

Site Status RECRUITING

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Prague, , Czechia

Site Status RECRUITING

Research Site

Créteil, , France

Site Status NOT_YET_RECRUITING

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La Rochelle, , France

Site Status NOT_YET_RECRUITING

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La Tronche, , France

Site Status NOT_YET_RECRUITING

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Montpellier, , France

Site Status NOT_YET_RECRUITING

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Nantes, , France

Site Status NOT_YET_RECRUITING

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Paris, , France

Site Status NOT_YET_RECRUITING

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Toulouse, , France

Site Status NOT_YET_RECRUITING

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Berlin, , Germany

Site Status RECRUITING

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Erlangen, , Germany

Site Status RECRUITING

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Lübeck, , Germany

Site Status NOT_YET_RECRUITING

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Mainz Am Rhein, , Germany

Site Status NOT_YET_RECRUITING

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Münster, , Germany

Site Status RECRUITING

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Bologna, , Italy

Site Status RECRUITING

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Milan, , Italy

Site Status NOT_YET_RECRUITING

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Milan, , Italy

Site Status NOT_YET_RECRUITING

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Padua, , Italy

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Parma, , Italy

Site Status NOT_YET_RECRUITING

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Torino, , Italy

Site Status NOT_YET_RECRUITING

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Kyoto, , Japan

Site Status RECRUITING

Research Site

Suita-shi, , Japan

Site Status RECRUITING

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Bydgoszcz, , Poland

Site Status WITHDRAWN

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Gdansk, , Poland

Site Status NOT_YET_RECRUITING

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Poznan, , Poland

Site Status NOT_YET_RECRUITING

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Warsaw, , Poland

Site Status NOT_YET_RECRUITING

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Lisbon, , Portugal

Site Status NOT_YET_RECRUITING

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Lisbon, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

Site Status NOT_YET_RECRUITING

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Porto, , Portugal

Site Status RECRUITING

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Gyeonggi-do, , South Korea

Site Status RECRUITING

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Seoul, , South Korea

Site Status RECRUITING

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Seoul, , South Korea

Site Status RECRUITING

Research Site

Badajoz, , Spain

Site Status RECRUITING

Research Site

Barakaldo, , Spain

Site Status RECRUITING

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Barcelona, , Spain

Site Status RECRUITING

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Barcelona, , Spain

Site Status RECRUITING

Research Site

Barcelona, , Spain

Site Status RECRUITING

Research Site

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Research Site

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

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Cadiz, , Spain

Site Status NOT_YET_RECRUITING

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Córdoba, , Spain

Site Status RECRUITING

Research Site

Granada, , Spain

Site Status RECRUITING

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Madrid, , Spain

Site Status RECRUITING

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Málaga, , Spain

Site Status RECRUITING

Research Site

Valencia, , Spain

Site Status NOT_YET_RECRUITING

Research Site

Valencia, , Spain

Site Status RECRUITING

Research Site

Zaragoza, , Spain

Site Status RECRUITING

Research Site

Kaohsiung City, , Taiwan

Site Status RECRUITING

Research Site

Taichung, , Taiwan

Site Status NOT_YET_RECRUITING

Research Site

Taipei, , Taiwan

Site Status RECRUITING

Research Site

Taoyuan District, , Taiwan

Site Status NOT_YET_RECRUITING

Research Site

Leeds, , United Kingdom

Site Status RECRUITING

Research Site

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Research Site

London, , United Kingdom

Site Status RECRUITING

Research Site

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Research Site

Woodville South, , United Kingdom

Site Status RECRUITING

Countries

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United States Argentina Australia Austria Brazil Canada China Czechia France Germany Italy Japan Poland Portugal South Korea Spain Taiwan United Kingdom

Central Contacts

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Alexion Pharmaceuticals, Inc. (Sponsor)

Role: CONTACT

Phone: 1-855-752-2356

Email: [email protected]

Other Identifiers

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2024-517568-48

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D928EC00001

Identifier Type: -

Identifier Source: org_study_id